> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Grants Fast Track for Myelofibrosis Drug
- URL: https://www.fdaweb.com/fda-grants-fast-track-for-myelofibrosis-drug/
- Published: 2023-07-19T12:00:00.000Z
- Updated: 2026-09-14T18:45:01.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154913

FDA has granted Karyopharm Therapeutics fast track status for selinexor for treating patients with myelofibrosis, including primary myelofibrosis, post-essential thrombocythemia myelofibrosis, and post-polycythemia vera myelofibrosis. Currently, the company is evaluating the drug in a Phase 3 clinical trial (XPORT-MF-034) in combination with ruxolitinib in JAKi-naïve patients with myelofibrosis.

Karyopharm [presented](https://c212.net/c/link/?t=0&l=en&o=3921348-1&h=1256733220&u=https%3A%2F%2Finvestors.karyopharm.com%2F2023-06-28-Karyopharm-Initiates-Pivotal-Phase-3-Study-of-XPO1-Inhibitor-Selinexor-and-Ruxolitinib-in-JAK-Inhibitor-JAKi-Naive-Myelofibrosis&a=were+presented&ref=fdaweb.com) updated data from a Phase 1 study at several recent medical meetings. The data showed “rapid, deep and sustained spleen responses and robust symptom improvement in patients treated with selinexor 60 mg in combination with ruxolitinib as of the 4/10/2023 cut-off date,” it says. Top-line data from the ongoing Phase 3 study are expected in 2025.